CAPPS, A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen for the Treatment of Painful Diabetic Neuropathy
Ortho-McNeil Pharmaceutical Inc.
The objective of this study is to compare the analgesic efficacy and safety of tramadol HCl and acetaminophen versus placebo for the treatment of painful diabetic neuropathy.
ACCORD, Action to Control Cardiovascular Risk in Diabetes
Substudies: ACCORD-Mind and ACCORD-Eye
Sponsor and Initiator
National Heart Lung and Blood Institute (NHLBI), U.S. National Institutes of Health (NIH)
This trial addresses the challenges to cardiovascular health of persons with type 2 diabetes by testing three complementary medical treatment strategies. Participants are randomly assigned to a treatment regimen involving either aggressive or standard control of blood sugar. Then, depending on their blood pressure and cholesterol levels, they are assigned to either a blood pressure intervention or blood fat intervention.
ORIGIN, Outcome Reduction with Initial Glargine Intervention
ORIGIN is a 2×2 factorial study investigating the prevention of cardiovascular morbidity and mortality in people with type II diabetes, impaired glucose tolerance, and/or fasting glucose ≥110 mg/dL. The two factors are insulin glargine (Lantus) (variable dose vs. standard care), and omega-3 fatty acid (865mg vs. placebo). Participants are randomized to one of the four possible treatment combinations.
DREAM, Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication
DREAM is an international, multi-center, randomized, double-blinded, placebo-controlled trial involving 4,000 participants at high risk for developing type II diabetes mellitus. Participants receive ramipril (ACE-I) or placebo and rosiglitazone (TZD) or placebo (therefore, there are 4 treatment combinations possible). The goal is to determine which group has a lower prospective incidence of DM. The study also collects observational data useful for establishing epidemiological associations between cardiovascular disease and type II diabetes mellitus.